Generally, a party wishing to invalidate a patent will attack the process by which the patent was obtained rather than the substance of the discovery. This is because in most cases a third party wishes to practice the discovery and is blocked from doing so by an issued U.S. Patent. One common method of attacking validity is an attack on the data present in the patent. For example, when experiments disclosed in the original Application are repeated by others and the original teachings are found to be inoperable.
For chemical, especially pharmaceutical, applications, this requirement mandates that for new compositions of matter there be confirming analytical data that suggests the desired compound was in possession of the inventors and that an adequate process for preparing the compound be disclosed. For example, an application that merely provides a generic or specific chemical structure without some form of evidence, inter alia, 1H NMR, 13C NMR, mass spectrum and the like, would not be deemed “enabled” under the Patent Act.
In addition to verification of the structure, the Applicant must disclose a “use” for the molecule and one or more examples of that usage. For example, a method of treating cancer assertion together with in vitro or even in vivo supporting data. There are instances wherein a chemical compound or composition is discovered and patented and it is not until science advances that a new use of the compound is found. This article discusses one possible fatal flaw when contemporary patent Applications rely on decades old initial discoveries and the written description contained in the original patent Application. The question is: how does one prove that one actually has possession of the invention when there is a significant error in the original disclosure? What constitutes a fatal flaw in the patent’s disclosure? Is the misidentification of a chemical formula a fatal flaw that can invalidate a U.S. Patent?
In 1973 the German pharmaceutical company, Boehringer Ingleheim, obtained a German patent which disclosed a number of antiseizure medications. The patent disclosed the complete synthesis of an analog TIC10. Subsequently the National Cancer Institute (NCI) incorporated this compound into one of its databases.
In 2013 a researcher at Penn State, Wafik S. El-Deiry, reported that TIC10 demonstrated potential anticancer activity. The Penn State researchers used Boerhinger Ingleheim’s disclosed procedure for making this analog and confirmed the structure using mass spectrum analysis. The compound was then patented in 2014 (U.S. 8,673,932 B2) for use as a method for treating cancer. Penn State licensed the patent to Oncoceutics a drug development company founded by El-Deiry.
Upon learning of TIC10’s anti-cancer activity, a group led by Dr. Kim Janda at Scripps Institute decided to investigate this drug. They developed a shorter and higher yield synthesis of the compound having the formula published in El-Deiry’s patent. When the compound they prepared was tested it was found to be inactive. Janda secured a sample of TIC10 from the NCI data base and analyzed it using techniques not available to Boehringer Ingleheim 40 years earlier. It was found that the originally assigned structure was incorrect. Is Oncoceutic’s patent potentially invalid because of this error?
We believe the answers to the above questions can be found in Cubist Pharmaceuticals, Inc. v. Hospira Inc. (Fed. Cir. 2015). The District Court held that a patent was not invalid because of an incorrect chemical formula and that the error was correctible after the patent was issued. In upholding the District Court’s judgment, the Federal Circuit discussed the relationship between what is actually obtained and what is believed to be possessed. Supporting Pennsylvania State University in the patents under discussion, the court held that after detailed analysis of the state of knowledge at relevant times, there was a reasonable scientific explanation for the original erroneous disclosure which explanation allowed it to uphold the patents.
The court has reaffirmed by this decision that it is not a chemical formula that places possession of a discovery into patentee’s hands, but the ability to make the molecule by a recognized reproducible process. Prior to modern spectroscopy techniques, many patentees relied only on a reproducible process to show possession.
An important lesson from all of this for patent applicants and those contemplating a patent validity challenge is that an attack on a patent for misleading or incorrect disclosures during its prosecution must be considered in the context of the thenprevailing scientific environment in order to determine if there was a reasonable explanation for the error.